Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Screening Prostate Cancer

NCT05055843 | Active Not Recruiting

• 2 other identifiers: 2021-0273NCI-2021-05282
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies examines a 3D magnetic resonance imaging (MRI) compared to standard MRI imaging techniques in screening patients with prostate cancer. Diagnostic procedures, such as MRI, may help find and diagnose prostate cancer. Computer systems that allow doctors to create a 3-dimensional (3-D) picture of the tumor may help in planning.

Conditions

Prostate Adenocarcinoma; Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• To be assessed with scoring of quantitative image metrics in regions of prostate cancer and benign tissue

  Comparing the 2-dimensional (2D) T2W imaging technique without endorectal coil. Scored from 1 to 5 with PI-RADS 1 indicating that csPCa is highly unlikely whereas a PI-RADS 5 score indicates that csPCa is highly likely to be present.

  through study completion, an average of 1 year

Study Arms (1)

Screening (3D MRI)

EXPERIMENTAL

Patients undergo 3D MRI imaging over 15 minutes with standard of care MRI or at a separate time.

Procedure: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging PROCEDURE

Undergo 3D MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Screening (3D MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, age \>= 18
• Untreated, biopsy-proven with intermediate and high-risk adenocarcinoma of the prostate
• Patient is being considered for curative-intent treatment with radical prostatectomy
• Patient has provided written informed consent for participation in this trial
• Patient should be eligible for scanning on a 3T magnet

You may not qualify if:

• Low-risk adenocarcinoma of prostate
• Any prior therapy for prostate cancer
• A history of other active malignancy within the last 2 years
• Prostate cancer with significant sarcomatoid, spindle cell, or neuroendocrine small cell components
• Cardiac pacemaker
• Orthopedic hardware in the pelvis and spine
• Claustrophobia

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Tharakeswara Bathala

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: September 24, 2021
• Study Start: August 10, 2021
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)